ID

34557

Description

Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01559103

Link

https://clinicaltrials.gov/show/NCT01559103

Keywords

  1. 1/19/19 1/19/19 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 19, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT01559103

Eligibility Rheumatoid Arthritis NCT01559103

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
active rheumatoid arthritis (ra) for 6 months or more.
Description

ID.1

Data type

boolean

males or nonpregnant, nonlactating femails aged 20 to 75 years, inclusive.
Description

ID.2

Data type

boolean

body mass index (bmi) between 19 and 36 kg/m2 and weight between 50 and 145 kg, inclusive.
Description

ID.3

Data type

boolean

males, unless surgically sterile, must use 2 effective methods of birth control from day 1 through follow-up.
Description

ID.4

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history or presence of any clinically significant disease or disorder which has not been stable over the previous 3 months.
Description

ID.5

Data type

boolean

history of liver disease, bilirubin elevations, or gilbert's syndrome.
Description

ID.6

Data type

boolean

any systematic inflammatory condition in addition to ra (polymyalgia rheumatica, giant cell arthritis, systemic lupus, gout, pyrophosphate arthropathy).
Description

ID.7

Data type

boolean

current, chronic pain disorders including fibromyalgia and chronic regional pain syndromes or chronic fatigue syndromes.
Description

ID.8

Data type

boolean

intramuscular steroid injection or intraarticular steroid injection within 1 month of enrollment.
Description

ID.9

Data type

boolean

Similar models

Eligibility Rheumatoid Arthritis NCT01559103

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
active rheumatoid arthritis (ra) for 6 months or more.
boolean
ID.2
Item
males or nonpregnant, nonlactating femails aged 20 to 75 years, inclusive.
boolean
ID.3
Item
body mass index (bmi) between 19 and 36 kg/m2 and weight between 50 and 145 kg, inclusive.
boolean
ID.4
Item
males, unless surgically sterile, must use 2 effective methods of birth control from day 1 through follow-up.
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
Item
history or presence of any clinically significant disease or disorder which has not been stable over the previous 3 months.
boolean
ID.6
Item
history of liver disease, bilirubin elevations, or gilbert's syndrome.
boolean
ID.7
Item
any systematic inflammatory condition in addition to ra (polymyalgia rheumatica, giant cell arthritis, systemic lupus, gout, pyrophosphate arthropathy).
boolean
ID.8
Item
current, chronic pain disorders including fibromyalgia and chronic regional pain syndromes or chronic fatigue syndromes.
boolean
ID.9
Item
intramuscular steroid injection or intraarticular steroid injection within 1 month of enrollment.
boolean

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